Insertion device
An insertion apparatus and a method for use with a device for delivery of a therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte are disclosed. The apparatus includes a housing adapted for loading therein at least one cannula cartridge unit having a protective member. The protective member accommodates at least one penetrating cartridge having a subcutaneously insertable element and a penetrating member. The apparatus includes a displacement mechanism capable of protracting the penetrating cartridge towards the body of the patient, where protraction of the penetrating cartridge results in insertion of the subcutaneously insertable element into the body of the patient.
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The present application claims priority to U.S. Provisional Patent Application No. 60/937,214, entitled “Insertion Device for Inserting a Cannula into a Body”, U.S. Provisional Patent Application No. 60/937,155, entitled “Protector for Cannula and Penetrating Member Insertable in the Body of a Patient”, and U.S. Provisional Patent Application No. 60/937,163, entitled “Devices and Methods for Pain Reduction”, all filed on Jun. 25, 2007, the disclosures of which are incorporated herein by reference in their entireties.
FIELD OF THE INVENTIONThe present invention generally relates to medical devices, and particularly to devices that administer medication into the body of a patient and/or sense analyte levels in a bodily fluid. More particularly, some embodiments of the present invention are directed to an insertion device and a method for manual or automatic insertion of a cannula into a human body for delivering a drug using a skin adherable patch unit and/or for continuous sensing of a bodily analyte.
BACKGROUND OF THE INVENTIONContinuous subcutaneous delivery of medication or monitoring of a body analyte is often accomplished using a cannula inserted into a human body that remains in place for several days. Diabetes patients may use such cannula, which is positioned in a subcutaneous compartment for continuous delivery of insulin by pumps or for monitoring interstitial glucose levels by sensors. A combination of a tube connecting the insulin pump to the cannula and a detachable connector is often referred to as an infusion set. Such infusion sets and modes of their insertion are disclosed, for example, in U.S. Pat. Nos. 4,755,173, 5,176,662 and 5,257,980. Subcutaneous cannula insertion modes for continuous glucose monitoring are discussed, for example, in U.S. Pat. Nos. 5,390,671, 5,568,806 and 5,586,553. Usually, trans-cutaneous (“hypodermic”) cannula insertion can be carried out with a sharp metal penetrating member to be withdrawn after skin piercing. This procedure can be carried out manually by the user/patient. The insertion is usually painful and requires considerable skill. Some patients are reluctant or hesitant to pierce their own skin, and thus, encounter difficulties in proper cannula insertion. Such difficulties can be attributed to insufficient manual dexterity or, alternatively, to anxiety associated with anticipated discomfort as the needle pierces the skin. This problem can be especially significant when an insulin pump is used, since misplacement of the cannula can cause kinking, incorrect insertion angle or incorrect cannula insertion depth leading eventually to cannula obstruction. As a result, delivery of insulin could be hampered thereby causing a life-threatening situation.
In an attempt to cope with this problem, automatic infusion set insertion devices (“inserters”) were developed to assure correct placement of a cannula into the subcutaneous layer at a correct angle while minimizing pain and hazardous obstructions associated with cannula insertion. U.S. Pat. Nos. 6,093,172 and 6,830,562 disclose inserters having a spring-loaded plunger for an automatic subcutaneous placement of an infusion set. These automatic inserters can be used with “pager like” pumps having long tubing and a cannula altogether constituting an “infusion set”. However, these devices cannot be used for insertion of a cannula used with skin adherable pumps that do not employ long tubing. Such device is discussed in U.S. Pat. No. 6,699,218 to Flaherty et al. In Flaherty's skin adherable device, the cannula is rigidly connected to the pump's housing. After adhesion to user's skin, the cannula is fired, thereby emerging from the device's housing and piercing the skin. Consecutively, the penetrating member is retracted back into the pump's housing. This device is relatively bulky, heavy and indiscreet because the spring-loaded mechanism is deployed within the device's housing during the entire period of usage. In addition, the cannula has only a single length size and penetrates the skin only at a certain angle; the patient cannot adjust these parameters based on various insertion sites and other clinical requirements.
Continuous glucose monitors are disclosed in U.S. Pat. Nos. 5,390,671 and 6,143,164, assigned to MiniMed and E. Heller & Company, respectively. These devices monitor glucose levels in the subcutaneous compartment using a sensor, which is inserted manually or automatically in a fashion similar to the insertion of a cannula, as disclosed in U.S. Pat. No. 7,110,803, assigned to DexCom.
Thus, it would be desirable to provide improved systems and methods for inserting a cannula and/or sensor into the body of a patient.
SUMMARY OF THE INVENTIONIn some embodiments, the present invention relates to a device and a method for automatic insertion of a sensor, which can be suitable for continuous analyte (e.g., glucose) monitoring and which can be adhered to a patient's skin. The present invention also relates to an automatic insertion of a cannula (e.g., a single cannula or multiple cannulae) that can be used for delivery of medication (e.g., insulin) and can be used for continuous monitoring of body analyte (e.g., glucose). In some embodiments, the present invention relates to an automatic insertion of two cannulae coupled to a single patch, wherein one cannula is used for delivery of medication and the other for continuous monitoring of a bodily analyte. For example, a patch could include one cannula for drug delivery and one sensor for sensing analytes. The present invention further allows insertion of a cannula at any desired depth, i.e., the user can choose the desired cannula length size. Further, the cannula can be inserted at any desired angle.
In some embodiments, the cannula insertion device can fit comfortably in the user's hand. The cannula insertion device can include minimal number of parts, which is easy to assemble, and which is inexpensive. In some embodiments, the cannula insertion device can be either reusable or disposable.
In some embodiments, the present invention relates to an inserter device for a precise placement of a cannula within a body of a user. The device can be used for automatic insertion of a cannula that is employed together with, for example, a fluid dispensing device (which is also referred to herein as a fluid delivery pump). The pump can be configured as a remote-controlled skin adherable patch (also, referred to herein as a dispensing patch unit) allowing programmed fluid delivery. The pump also can include means for continuous analyte level monitoring. In some embodiments, the dispensed fluid is insulin and the monitored analyte is glucose. In some embodiments, the dispensing device includes the following three units:
1. A dispensing patch unit having:
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- a. A reusable part containing a driving mechanism, a printed circuit board (“PCB”), and electronics.
- b. A disposable part containing a reservoir, a delivery tube and an outlet port with a connecting lumen.
2. A cradle unit for connecting and reconnecting the dispensing patch unit to the body. The cradle has a tubular passage, referred to as “well”, for allowing cannula penetration of the skin. The cradle also has an adhesive layer for attachment to the body.
3. A cannula cartridge unit, which can be a disposable item. The cannula cartridge unit includes a cannula, a penetrating member, and a protector. The cannula is also provided with a hub disposed within the cannula cartridge unit and which contains a rubber septum that can be repeatedly pierced by a connecting lumen provided in the disposable part of the dispensing patch unit.
A method for setting up the above system can include the following steps:
1. fill the reservoir with therapeutic fluid;
2. assemble the dispensing patch unit from two parts (i.e., a disposable part and a reusable part);
3. adhere the cradle unit to the skin of the user (in some embodiments, this step can be performed after connecting the inserter to the cradle unit);
4. insert cannula, where this step includes:
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- a. load the cannula cartridge unit into the inserter (in some embodiments, this step can be performed after connecting the inserter to the cradle unit);
- b. connect the inserter to the cradle unit;
- c. advance the cannula, either automatically or manually, through the cradle unit towards the body, thereby piercing the skin and disposing the cannula in the subcutaneous compartment; and,
- d. withdraw the penetrating member, either automatically or manually, from the body into the protector, while the cannula remains in the cradle unit;
5. connect the dispensing patch unit to the cradle unit, such that a connecting lumen emerges from the disposable part's outlet port and pierces the cannula hub's rubber septum to maintain fluid communication between the reservoir, the delivery tube, the cannula and the subcutaneous tissue;
6. using a remote control unit, program fluid delivery.
In some embodiments, the cannula delivering the fluid (e.g., insulin) also includes a sensor for monitoring a bodily analyte (e.g., glucose). Fluid delivery can be adjusted based on sensor inputs (in a semi- or fully-closed-loop system). In some embodiments, the dispensing patch unit can include both the cannula for fluid delivery and a sensor for analyte sensing, which can both be inserted into the body.
In some embodiments, the present invention relates to an automatic insertion of the cannula for delivery of medication to a patient using the fluid delivery skin adherable patch pump.
In some embodiments, the present invention relates to an automatic insertion of a sensor suitable for continuous analyte monitoring and that can be adhered to the skin of the patient.
In some embodiments, the present invention relates to an automatic insertion of a single cannula that can be used for delivery of medication (e.g., insulin) and for continuously monitoring of body analyte (e.g., glucose).
In some embodiments, the present invention relates to an automatic insertion of two cannulae coupled to one patch, where one cannula is used for delivery of medication and the other for continuously monitoring a body analyte. In some embodiments, the patch contains one cannula for drug delivery and one sensor for sensing and monitoring analytes.
In some embodiments, the present invention relates to manual and/or automatic insertion of a cannula that can pass through a “well assembly” and be inserted into a subcutaneous compartment. In some embodiments, the cannula can pass through a “cradle unit” and be inserted into the subcutaneous compartment. The cannula can be inserted at any desired depth, i.e., the user can choose the desired cannula length size and/or any desired angle.
In some embodiments, the cannula can be inserted and the penetrating member can be retracted manually. In some embodiments, insertion of the cannula and retraction of the penetrating member are automatic. In some embodiments, insertion of the cannula is automatic and retraction of the penetrating member is manual.
In some embodiments, a cannula insertion device allows precise alignment of the cannula relative to the “well assembly”. Highly accurate alignment is desirable for the following reasons: 1) it avoids tearing of the well's lower gasket, thus, maintaining intact sealing; 2) it permits skin penetration at any desired angle; 3) it provides sealing of the upper opening with the rubber cap; and 4) it allows precise placement of the cannula within the well and maintenance of flow communication. In some embodiments, the cannula insertion device maintains precise alignment of the cannula relative to the “cradle unit” and maintains connection of the cannula to the cradle after insertion. In some embodiments, the cannula insertion device can be connected to the cradle unit before adhesion and used as a means for attaching the cradle unit to the patient's body. In some embodiments, the cannula insertion device can be automatically detached from the cradle unit after the cannula has been inserted, for example, to avoid unintentional detachment of the cradle from the skin.
In some embodiments, the cannula insertion device is spring-loaded. The spring can be loaded by the patient and released upon patient's discretion. The inserter can be configured to prevent unintentional or premature firing. In some embodiments, the cannula insertion device is suitable for use in conjunction with a cannula protector. The cannula protector can be easily manipulated by the user and may be receivable within the inserter and positioned in a single spatial direction. In some embodiments, the cannula insertion device fits comfortably in the user's hand. In some embodiments, the cannula insertion device has relatively few parts, which are easy to assemble and are inexpensive. The cannula insertion device can be reusable. In other embodiments, the cannula insertion device can be disposable.
In some embodiments, the present invention relates to an automatic insertion of the cannula and/or the sensor used in association with the skin adherable infusion pump having analyte sensing and drug dispensing capabilities and in which the fluid dispensing can be adjusted according to analyte sensing (in semi- or fully-closed loop mode). In some embodiments, the inserter can be preloaded with the cannula cartridge unit and the cradle unit. Upon spring loading, the user attaches the cradle unit to the skin and pushes a release button. A spring loaded flywheel forcibly pushes the cannula and the penetrating member through the well into the body. Consecutively, the penetrating member is automatically retracted into the protector while the cannula hub remains connected to the well. Finally, the inserter is detached from the cradle unit and the protector (with penetrating member inside) is unloaded from the inserter and is disposed of. In some embodiments, the inserter can be preloaded with at least one (or more than one) cannula cartridge unit.
In some embodiments, the present invention includes a disposable inserter preloaded with the cannula cartridge unit and after cannula insertion, the used protector (with the penetrating member inside) remains within the inserter's housing, which is then can be discarded.
In some embodiments, the present invention provides an inserter that allows for passing of the cannula through the well assembly and its penetration through the skin. After insertion, the cannula remains in the body, the cannula hub is secured to the well and the penetrating member can be retracted. In some embodiments, the inserter enables alignment of the cannula with the cradle unit. In some embodiments, the inserter enables alignment of the cannula with the outlet port in the dispensing patch unit's housing and the passage of the well assembly. In some embodiments, the inserter includes a drum member suitable for retaining one or more cannula cartridge units. In some embodiments, the inserter contains safety means for preventing inadvertent or premature insertion. The safety means may be an integral part of the inserter or it may be an additional component which is detachable from the inserter before operation. In some embodiments, safety means are provided for disposing of the sharp penetrating member after manual retraction of penetrating member from the body.
For a better understanding of the present invention, including the various objects and advantages thereof, reference is made to the following description, which is to be taken in conjunction with the accompanying illustrative drawings.
A skin adherable insulin delivery device was disclosed in a co-owned/co-pending International Patent Application No. PCT/IL07/000932, filed Jul. 24, 2007, claiming priority to U.S. Provisional Patent Application No. 60/833,110, filed Jul. 24, 2006, and U.S. Provisional Patent Application No. 60/837,877, filed Aug. 14, 2006, and also disclosed in a co-owned/co-pending U.S. patent application Ser. No. 12/004,837, and International Patent Application No. PCT/IL07001578, both filed Dec. 20, 2007 and both claiming priority to U.S. Provisional Patent Application No. 60/876,679, filed Dec. 22, 2006. The disclosures of the above applications are incorporated herein by reference in their entirety. The device contains a remote control unit and a skin adherable unit (“dispensing patch unit”). The dispensing patch unit is coupled to a unique cannula apparatus, which does not require an infusion set and long tubing. The cannula apparatus allows the patient to choose the desired depth and angle for cannula insertion. In some embodiments, the device is provided with a “well assembly” connected to an insulin delivery tube. The well assembly has an upper opening and a lower opening sealed by rubber gasket. The insertion apparatus is provided also with a “penetrating cartridge” having a cannula, a penetrating member and a rubber cap. The penetrating cartridge allows for the cannula to penetrate through the well assembly and then through the skin, while keeping the upper opening sealed and maintaining the delivery of insulin. In some embodiments, the device includes a “cradle unit”. The cradle unit is configured as a sheet with an adhesive layer that is attached to the skin before cannula insertion, and is used to allow connection and disconnection of the dispensing patch unit to and from the body. The cannula is inserted through the cradle unit into the skin and remains secured at the cradle unit after insertion. The penetrating member, which is configured as a sharp needle, is then retracted and disposed of.
In co-pending, co-owned International Patent Application No. PCT/IL2008/000861 and U.S. patent application Ser. No. 12/215,219, entitled “Portable Infusion Pump with Cannula Inserter and Pain Reduction Mechanism” and “Protector Mechanism,” respectively, and claiming priority to U.S. Provisional Patent Application No. 60/937,155, filed on Jun. 25, 2007, a device and a method are disclosed for protecting the user from unintentional pricking by providing a protective cover that shields the penetrating cartridge, further referred to as a “protector.” The disclosures of the above applications are incorporated herein by reference in their entireties. The protector is detachably connectable to the cradle unit and consecutively the cannula can be manually or automatically inserted. Upon insertion and piercing of the skin, the penetrating member is retracted into the protector and both items can be disposed of.
Continuous glucose monitors are disclosed in a co-owned/co-pending International Patent Application No. PCT/IL07/001096, filed Sep. 5, 2007, claiming priority to U.S. Provisional Patent Applications No. 60/842,869, filed Sep. 6, 2006, and International Patent Application No. PCT/IL07/001177, filed Sep. 25, 2007, claiming priority to U.S. Provisional Patent Application No. 60/848,511, filed Sep. 29, 2006. The disclosures of the above applications are incorporated herein by reference in their entireties.
The further description of the invention deals mostly with insertion of a cannula. It should be borne in mind however that this description may be equally used for insertion of a sensor for sensing bodily analyte or any other subcutaneously insertable element.
In some embodiments, shown in
-
- a cradle base (300) configured as a flat sheet with an adhesive layer facing the skin (5) and provided with anchoring means (302), (304) on its upper side for connection and disconnection of the inserter and of the dispensing patch unit; and
- a well (310) configured as a tubular protrusion emerging upwardly from the cradle base (300) to allow alignment and appropriate connection between the cradle unit (20) and the inserter as well as between the cradle unit (20) and the dispensing patch unit (10) to allow for proper delivery of fluid from the dispensing patch unit (10) to the body.
The inserter (800) allows either automatic or manual protraction of the cannula (713) and the penetrating member (716) from the protector (710) into the body of the (i.e., a hypodermic cannula insertion), as will be described in detail below. Once the cannula and the penetrating member are protracted from the protector (710), the penetrating member (716) pierces the skin (5), thereby allowing insertion of the cannula (713). After insertion, the cannula (713) continues to remain in the body and the penetrating member (716) can be retracted back into the protector (710). The insertion process terminates with the unloading of the protector (710) (with the penetrating member (716) disposed inside) from the inserter (800) and disposal of the protector (710).
It will be noted that in embodiments where the protector (710) is not used, the penetrating cartridge (711) alone is disposed within the inserter (800). Thus, the insertion process can be carried out as disclosed in co-owned, co-pending International Patent Application No. PCT/IL07/001454, filed Nov. 26, 2007, claiming priority to U.S. Provisional Patent Application No. 60/861,345, filed Nov. 28, 2006, and U.S. patent application Ser. No. 12/004,837, and International Patent Application No. PCT/IL07001578, both filed Dec. 20, 2007 and both claiming priority to U.S. Provisional Patent Application No. 60/876,679, filed Dec. 22, 2006, the disclosures of which are incorporated herein by reference in their entireties.
As illustrated in
Various types of inserters can be loaded with the cannula cartridge unit (700).
The cannula insertion process can be carried out either manually (i.e., both the cannula insertion and the penetrating member retraction are performed manually), semi-automatically (i.e., the cannula insertion is automatic while the penetrating member retraction is manual or vice versa), or fully automatic (i.e., both the cannula insertion and the penetrating member retraction are performed automatically). The following figures illustrate in detail various types of insertion processes.
The rod (860) can include a handle (861) and a push rod portion (862) that can be located opposite the handle (861). The cannula cartridge unit (700) includes the penetrating cartridge (711) having the grip portion (712) that interacts with the push rod portion (862) of the rod (860). The push rod portion (862) can include a recessed portion (863) at its top that accommodates placement of the handle (861). The recessed portion (863) secures the handle (861) and prevents wobbling of the handle (861) when the latter is being pushed down the cannula cartridge unit (700). In another embodiment, the handle and the push rod portion are configured to constitute a single item.
In addition to triggers (809), (809′), the inserter (80) includes a spring (813) disposed inside the inserter (80), rod (815) having an annular depression (817) and being coupled to the spring (813), and spring latches (811), (811′) suspended on respective recesses (807), (807′) (which are disposed near the top portion of the inserter (80)), as shown in
The retraction process ends when the spring (813) is returned to its loaded state, and the spring latch protrusions (811), (811′) become suspended in their respective recesses (807), (807′). As the penetrating member (716) is retracted, the cannula hub (714) remains within the well (310). In some embodiments, the well (310) includes spring protrusions (715), (715′) to help retain the cannula hub (714) within the well (310).
As can be understood by one skilled in the art, the retraction of the penetrating member (716) can otherwise be carried out automatically, e.g., by employing a second retraction spring.
The protector (710) can then be unloaded from the inserter (80), as illustrated in
In the above embodiment, the cannula cartridge unit (700) can include a handle (720), as illustrated in
The inserter (90) includes a displacement mechanism that uses a spring-loaded flywheel. Thus, prior to loading the cannula cartridge unit (not shown) into the inserter (90), the user loads the flywheel torsion spring (922), as illustrated in
As can be understood by one skilled in the art, the displacement mechanism described above can be configured to allow automatic and/or manual displacement of the penetrating cartridge. In case of a manual displacement, a rod can be used to push the cartridge, as described above.
In some embodiments, the inserter discussed above with regard to
Thus it is seen that devices, systems and methods are provided for inserting a cannula into the body of a patient. Although particular embodiments have been disclosed herein in detail, this has been done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, it is contemplated that various substitutions, alterations, and modifications may be made without departing from the spirit and scope of the invention as defined by the claims. Other aspects, advantages, and modifications are considered to be within the scope of the following claims. The claims presented are representative of the inventions disclosed herein. Other, unclaimed inventions are also contemplated. The applicant reserves the right to pursue such inventions in later claims.
All of the foregoing patents, applications, and publications referenced in this specification are hereby incorporated by reference herein in their entireties.
Claims
1. A subcutaneous insertion apparatus comprising:
- a housing configured to receive at least one cartridge unit, the at least one cartridge unit comprising a protective member containing therein at least one subcutaneously insertable element and at least one penetrating member, the housing including: a first housing opening adapted for at least loading therethrough the at least one cartridge unit into the housing; and a second housing opening adapted for at least protracting therethrough the at least one insertable element and the at least one penetrating member; and
- a displacement mechanism contained within the housing and configured to at least protract the at least one insertable element and the at least one penetrating member through the second housing opening toward the body of the patient for subcutaneous insertion of the at least one insertable element,
- wherein the displacement mechanism is configured to be primed for activation prior to the housing receiving the at least one cartridge unit; and
- the insertion apparatus is configured to couple to a skin-securable cradle that comprises a tubular protrusion emerging upwardly from the cradle that defines therein a well, the well comprising a plurality of penetration tunnels for directing the subcutaneous insertable element toward a plurality of angles with respect to a plane of a bottom housing opening, and the insertion apparatus is configured to align the subcutaneous insertable element with any of the plurality of penetration tunnels of the well, so as to insert the subcutaneous insertable element through the aligned tunnel.
2. The insertion apparatus according to claim 1, wherein the displacement mechanism is further configured to retract the penetrating member into the protective member subsequent to the subcutaneous insertion of the insertable element.
3. The insertion apparatus according to claim 1, wherein the displacement mechanism comprises a rod for manually forcing the at least one insertable element and the at least one penetrating member toward the body of the patient.
4. The insertion apparatus according to claim 1, wherein the displacement mechanism includes a loadable spring, wherein unloading of the spring results in protraction of the at least one insertable element and the at least one penetrating member toward the body of the patient.
5. The insertion apparatus according to claim 4, wherein the displacement mechanism further comprises a second spring, wherein unloading of the second spring results in retraction of the penetrating member into the protective member subsequent to subcutaneous insertion of the insertable element.
6. The insertion apparatus according to claim 1, further comprising a user-actuated button for actuating the displacement mechanism when the cartridge unit is loaded therein.
7. The insertion apparatus according to claim 1, further comprising a safety means for preventing inadvertent actuation of the displacement mechanism.
8. The insertion apparatus according to claim 1, wherein the displacement mechanism comprises one or more hooks configured to engage with at least a portion of the cartridge unit when the cartridge unit is loaded within the housing.
9. The insertion apparatus according to claim 1, wherein the displacement mechanism comprises:
- a release button having a restraining arm;
- a ratchet flywheel;
- a loadable flywheel torsion spring at least a portion of which is embedded in the ratchet flywheel;
- a manually rotatable loading button capable of being coupled to the ratchet flywheel for loading the flywheel torsion spring;
- a ratchet crank coupled to the ratchet flywheel and rotatable by the flywheel torsion spring; and
- an insertion lever provided with at least one engagement hook and displaceable by the ratchet crank, wherein: upon coupling the loading button to the ratchet flywheel and subsequent rotation of the loading button the flywheel torsion spring is loaded, upon actuation of the release button, the restraining arm of the release button is disengaged from the ratchet crank allowing the ratchet crank to rotate via an application of force of the loaded flywheel torsion spring, and the ratchet crank displaces the insertion lever and the at least one engagement hook resulting in the protraction of the at least one insertable element and the at least one penetrating member toward the body of the patient and, subsequently, the retraction of the penetrating member, thereby retaining the insertable element in the body of the patient.
10. The insertion apparatus according to claim 1, wherein at least one of the first and second housing openings is further configured for unloading therethrough at least a portion of the at least one cartridge unit from the housing.
11. The insertion apparatus according to claim 1, wherein the first housing opening is further configured for unloading therethrough the protective member with at least the penetrating member contained therein from the housing.
12. The insertion apparatus according to claim 1, wherein the insertion apparatus is configured for repetitive use via subsequent loading of one or more additional cartridge units.
13. The insertion apparatus according to claim 1, wherein the housing further includes a securing mechanism configured to secure the at least one cartridge unit to the housing upon loading the at least one cartridge unit into the housing.
14. The insertion apparatus according to claim 1, wherein the first housing opening is a side opening.
15. The insertion apparatus according to claim 1, wherein the second housing opening is a bottom opening.
16. The insertion apparatus according to claim 1, wherein the second housing opening is separate from the first housing opening.
17. The insertion apparatus according to claim 1, wherein the housing further comprises one or more recesses configured to engage with one or more corresponding protrusions of the cradle for connecting the insertion apparatus to the cradle.
18. The insertion apparatus according to claim 1, further comprising a mechanism for disconnecting the insertion apparatus from the cradle unit.
19. The subcutaneous insertion apparatus of claim 1, further comprising a selection mechanism configured to set an angle of the insertable element from the plurality of angles with respect to the plane of the bottom housing opening, the selection mechanism comprising a button coupled to the cartridge unit, wherein rotation of the button rotates the cartridge unit in a corresponding direction.
20. The subcutaneous insertion apparatus of claim 1, further comprising a depth selection mechanism configured to set a depth of insertion of the at least one penetrating member.
21. A subcutaneous insertion apparatus comprising:
- a housing configured to receive at least one cartridge unit, the at least one cartridge unit comprising a protective member containing therein at least one subcutaneously insertable element and at least one penetrating member, the housing including: a side housing opening adapted for at least loading therethrough the at least one cartridge unit into the housing, and a bottom housing opening adapted for at least protracting therethrough the at least one insertable element and the at least one penetrating member; and
- a displacement mechanism contained within the housing and configured to at least protract the at least one insertable element and the at least one penetrating member through the second housing opening towards the body of the patient for subcutaneous insertion of the at least one insertable element,
- wherein the displacement mechanism is configured to be primed for activation prior to the housing receiving the at least one cartridge unit; and
- the insertion apparatus is configured to couple to a skin-securable cradle that comprises a tubular protrusion emerging upwardly from the cradle that defines therein a well, the well comprising a plurality of penetration tunnels for directing the subcutaneous insertable element toward a plurality of angles with respect to a plane of a bottom housing opening and configured to serve as a stopper to prevent excessive insertion of the at least one penetrating member and to hold a hub of the at least one subcutaneously insertable element upon retraction of the penetrating member, and the insertion apparatus is configured align the subcutaneous insertable element with any of the plurality of penetration tunnels of the well, so as to insert the subcutaneous insertable element through the aligned tunnel.
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Type: Grant
Filed: Jun 25, 2008
Date of Patent: Nov 7, 2017
Patent Publication Number: 20080319414
Assignee: Roche Diabetes Care, Inc. (Indianapolis, IN)
Inventors: Ofer Yodfat (Maccabim-Reut), Avraham Neta (Misgav), Illai Gescheit (Misgav)
Primary Examiner: Bhisma Mehta
Assistant Examiner: Larry R Wilson
Application Number: 12/215,255
International Classification: A61M 5/142 (20060101); A61B 5/00 (20060101); A61M 5/158 (20060101); A61M 5/42 (20060101); A61B 5/145 (20060101); A61M 5/14 (20060101);